tbuckley/cabot-search huggingface dataset:
Associations between patient-perceived cancer curability and advance directive completion based on race and ethnicity and cancer type.
Authors: Cameron Pywell, Nicole E. Caston, Star Ye, Gabrielle Betty Rocque
Journal: Journal of Clinical Oncology (2022)

200 Background: Despite Advance Care Planning (ACP) recommendations for patients with cancer for over 20 years, uptake remains low, and many such patients lack Advance Directives (AD). Our previous data showed a lack of association between patient-perceived cancer incurability and AD completion, however less is known about whether this relationship remains for key subgroups where perceptions may differ, such as BIPOC (Black, Indigenous, or People of Color) patients and patients with incurable hematologic malignancies. Methods: This cross-sectional study used Patient Reported Outcomes (PRO) from surveys administered during routine outpatient care at the University of Alabama at Birmingham from 12/2016 to 08/2021. Patients self-reported AD completion and perception of curability. Demographics consisting of age, sex, race and ethnicity, and marital status, and clinical characteristics, namely cancer type, cancer stage (stage 0-III grouped as early vs. IV/progression/recurrence as late) and phase of care (initial being the first 12 months, survivorship starting after this, and end of life being the last 6 months of life) were abstracted from the electronic medical record. Descriptive statistics were calculated using frequencies and percentages for categorical variables and median and interquartile ranges (IQR) for continuous variables. Likelihood ratios (LR) and 95% confidence intervals (CI) were estimated using a modified Poisson regression with robust error variance to evaluate the relationships between patient-perceived incurability and AD completion. Models were subset for White patients (n = 879), BIPOC patients (n = 330), and patients with solid organ malignancies (n = 987). Models were adjusted for demographics and clinical characteristics. Results: Of 1209 patients, 73% were White, and 82% had solid organ malignancies, most commonly gynecologic (32%), breast (17%), and gastrointestinal (13%). The sample was predominantly female (70%) with early-stage disease (60%) and a median age of 66 (IQR 58-72). AD completion was 46%, 32%, and 41% for patients who were White, BIPOC, or had solid organ malignancies, respectively. In adjusted analyses, patient-perceived incurability was not associated with AD completion for any of the patient subgroups (White LR 1.06, 95% CI 0.89-1.35; BIPOC LR 0.93, 95% CI 0.60-1.44; solid organ LR 1.10, 95% CI 0.88-1.36). Conclusions: Patient-perception of incurability does not appear to be associated with AD completion even in subgroup analyses based on race and ethnicity or cancer type.
Standardization of data collection in the initial medical history: Implementation of an improvement plan in an oncology department.
Authors: Martín Igor Gómez-Randulfe Rodríguez, Guillermo Alonso-Jáudenes Curbera, Beatriz Alonso de Castro, Sofia Silva Diaz, Iria Parajó Vázquez, Rosario Garcia Campelo
Journal: Journal of Clinical Oncology (2022)

306 Background: Non-standardized data collection in medical records has a negative impact on the quality of care: it increases the possibility of medical errors, hinders the performance of clinical studies, precludes the development of improvement plans and impedes accreditation in quality-of-care programs. The ASCO QOPI (Quality Oncology Practice Initiative) certification program accredits the quality of care of oncology departments through a self-assessment process. An overall quality score (OQS) above 75% on 26 measures that focus on quality of care and patient safety is required for application. In order to begin the certification process, we analysed the quality of the data collected in our initial medical history to implement improvement actions. Methods: Based on the 26 QOPI measures, plus 17 additional measures that were chosen by consensus as relevant, we performed a retrospective baseline analysis of the data collected in the initial medical history of patients assessed in June 2021. Patients with breast cancer, colorectal cancer and non-small cell lung carcinomas who initiated systemic treatment were included. Those who participated in clinical trials were excluded. The OQS of the 26 patients analyzed was 59%. Given this negative result, and once the problem was identified, the objective was established (OQS &gt; 75%), changes were prioritized and an improvement plan was developed based on rounds of training, feedback and reinforcement to the entire medical team, and through the design of a template with the essential data to be collected. Results: With the baseline result of June 2021 (n = 26; OQS = 59%), improvement rounds were performed in November 2021 (n = 29; OQS = 82%), December 2021 (n = 26; OQS = 74%), January 2002 (n = 35; OQS = 75%), February 2022 (n = 32; OQS = 78%) and March 2022 (n = 31; OQS = 79%). Conclusions: Correct data collection in medical records is essential for quality of care. Simple short-term measures based on training, feedback and reinforcement, and the creation of a data template, have increased OQS from 59% to exceed the 75% threshold required by QOPI to apply for the certification program. However, a long-term sustainable plan needs to be established through the introduction of computerized checklists in the free-text electronic medical history.
Palliative radiation therapy pathway for patients on hospice in a statewide quality improvement collaborative.
Authors: Natalia Simon, Thomas Pence Boike, Kiran Devisetty, Sam Beusterien, Kelly DeVries, Jennifer J. Griggs
Journal: Journal of Clinical Oncology (2022)

201 Background: Patients on hospice receive care directed at alleviating symptoms with the goal of reducing burdensome and unnecessary healthcare. Single-fraction radiation therapy is an effective palliative treatment for cancer‐related bleeding. Hospice physicians and radiation oncologists are driven by the same goals of relieving symptoms and decreasing the burden of treatment. In general, hospices are not able to support the costs of providing palliative radiation in eligible patients. The inability to receive radiation therapy may pose a barrier to hospice enrollment. Methods: The Michigan Oncology Quality Consortium (MOQC), a collaborative of nearly 90% of oncologists in Michigan, partnered with radiation oncologists, hospice directors, and patients and caregivers to create a pathway for the referral and treatment of patients with cancer-related bleeding. Through regular meetings, the collaboration created a pathway for patients on hospice or eligible for hospice who were candidates for palliative radiation therapy for bleeding. In patients with cancer-related bleeding, the hospice clinician collaborates with a participating radiation oncologist to confirm eligibility. This decreases the hospice costs of treatment, increases access to palliative radiation, and alleviates the financial and emotional burdens on the patient and family. Results: In Michigan radiation oncology practices and hospices with statewide representation approved the pathway. Radiation oncologists in 19 practices across the state agreed to high value radiation treatment (focused level 3 consultation, complex isodose planning, single fraction treatment). Eligible patients may be seen via virtual consultation and then treated within 1 to 2 days with a single fraction of 8 Gy. A second fraction can be given in patients who continue to have bleeding. MOQC established direct connection to members of the collaborative whose contact information is available on MOQC website. In addition to this treatment pathway, the previously adopted palliative radiation pathway for oncology patients with bone metastases may be found on MOQC website. Conclusions: The radiation therapy pathway for patients with bleeding ensures a unified approach to providing a patient-focused care in patients with limited life expectancy. Challenges to the implementation of the pathway include dissemination of the document across over 100 Michigan hospices and the upfront effort required to screen patients.[Table: see text]
Evaluation of the impact of an oncology urgent care clinic on preventable emergency department visits.
Authors: Brian Russell, Ashley L. O’Donoghue, Tenzin Dechen, Emma M. Lee, Aya Sato-DiLorenzo, Jennifer P. Stevens, Jessica Ann Zerillo
Journal: Journal of Clinical Oncology (2022)

338 Background: OP-35 is a publicly reported quality metric aimed at reducing preventable emergency department (ED) visits and hospitalizations in patients with cancer on chemotherapy. During the COVID-19 surge, one academic medical center opened the Respiratory Emergent Evaluation Service (REES) Unit, an urgent care clinic for patients with cancer and symptoms of COVID-19. In addition to preventing potential COVID-19 exposures in the clinic, this oncology-staffed urgent care evaluated patients who may have otherwise presented to the ED. We investigated the association between the REES urgent care clinic and patient ED evaluations for OP-35 diagnoses. Methods: This single center retrospective analysis included patients with cancer receiving infusion and oral chemotherapy who presented to the ED within 30 days of treatment. ED visits occurred between 1/2019-12/2021, including when the REES unit was open (3/2020-6/2021). Preventable ED visits were defined as having one of ten primary diagnoses, which have been identified by OP-35. Of these, COVID-related diagnoses included fever, pneumonia, sepsis, neutropenia and diarrhea. Interrupted time series analyses were utilized to investigate the association between the REES unit opening and preventable ED visits. Results: 3,107 patients on chemotherapy were assessed in the ED from 1/2019-12/2021. Per week, there were 19.9 ED visits, 39.7% of which were for OP-35 diagnoses. When the REES unit opened, there was a 30% (95% CI -53% to -7%) reduction in preventable ED visits, corresponding to 2.62 (95% CI -4.61 to -0.63) fewer preventable ED evaluations per week. The primary driver of this reduction were presentations for COVID-related diagnoses, as there were 38% (95% CI -76% to -0.3%) fewer preventable ED visits weekly. During this period, there were approximately 6.9 patient visits per week to the REES unit. Conclusions: The introduction of an oncology urgent care clinic focusing on patients with symptoms of COVID-19 was associated with a reduction in potentially preventable ED visits. This analysis demonstrates the potential value of oncology urgent care clinics in reducing ED overcrowding and decreasing OP-35 related evaluations, which has patient experience, infection exposure and financial implications.[Table: see text]
Evaluating factors contributing to low rates of breast cancer clinical trial accrual in a diverse patient population.
Authors: Emily L Podany, Shaun Bulsara, Katherine Sanchez, Hoda Badr, Maria Jibaja-Weiss, Maryam Nemati Shafaee
Journal: Journal of Clinical Oncology (2022)

100 Background: In an ideal world, the populations studied in cancer clinical trials (CCT) would be representative of the patients seen in clinic. Unfortunately, significant disparities exist in trial enrollment. Patients who are white, male, insured, or of high socioeconomic status (SES) are overrepresented in NCI-sponsored CCT. Despite data indicating equal willingness for participation in CCT across all racial groups, lack of access, cultural barriers, and social determinants of health contribute to poor accrual rates among racial and ethnic minority patients. The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) provides equal access to breast CCT at Smith Clinic (SC) within the safety-net Harris Health system and Baylor St. Luke’s Medical Center (BSLMC). The patient populations differ greatly at these two sites, with BSLMC serving &gt; 95% insured, largely Caucasian patients, and SC serving 60% uninsured, mostly low SES patients, with &gt; 80% racial and ethnic minorities. Despite equal access, patients at SC have a significantly higher CCT refusal rate. Methods: We performed a retrospective review of a prospectively maintained database of new patients seen at DLDCCC dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCT. 366 patients were found to be eligible for CCT. Some patients were eligible for multiple CCT, so there were 431 total offers of CCT. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the observed differences in CCT enrollment rates. Results: In the BSLMC cohort, 61% (116/204) of eligible patients enrolled in a CCT, while in the SC cohort only 39% (74/227) of eligible patients elected to enroll in CCT. This difference was significant on univariate but not multivariate analysis. There were significant differences when comparing race and trial type in the overall patient set. On univariate analysis, SC patients, African American (AA) patients, Hispanic/Latino patients, and Spanish speaking patients were significantly more likely to decline CCT participation. However, on multivariate analysis, only the AA patient category was associated with enrollment refusal (odds ratio 0.261, 95% CI 0.116-0.563, p &lt; 0.001). On both univariate and multivariate analyses, patients were significantly more likely to accept biobanking trials (multivariate: odds ratio 12.799, 95% CI 3.777-61.403, p &lt; 0.001). Conclusions: Based on these findings, it is likely an oversimplification to assume that equal access will lead to a complete elimination of CCT disparities. Our AA patients were significantly less likely to agree to participate in clinical trials, challenging the commonly held view that lack of access is a major barrier. We are exploring interventions designed to improve our AA patient population’s views of trial enrollment.
A pilot study to increase cascade genetic risk education and testing in families with hereditary cancer syndromes.
Authors: Steven Katz, Sarah T. Hawley, Rachel Tocco, Allison W. Kurian
Journal: Journal of Clinical Oncology (2022)

378 Background: There is great need to build and evaluate tools and strategies to improve cascade genetic risk evaluation in families at high risk for hereditary cancer. The Genetic Information and Family Testing (GIFT) Trial is a population-based intervention that will examine features of a virtual platform that provides genetic risk education (GRE) and low-cost genetic testing (GT) to relatives of 5000 adult patients diagnosed with cancer in 2018-19 in Georgia and California and who tested positive for a clinically actionable germline pathogenic variant (PV). We present findings of a pilot study that informed the GIFT Trial protocol and platform features. Methods: We surveyed 277 women diagnosed with breast cancer in 2017, reported to the Georgia SEER registry, and who tested positive for a clinically actionable PV in a cancer-associated gene. We then invited respondent patients to enroll in the intervention phase which provided online GRE, human pretest genetic navigator support, and an offer of low-cost GT through Color Health, Inc. to all untested 1st or 2nd degree relatives. Respondent patients were eligible for the intervention if they reported a PV on genetic testing and had at least one relative who had not received GT. Enrolled patients invited relatives through the platform by providing email addresses. Family clusters were block randomized to free vs $50 test costs at the time of the initial patient invitation. Results: 125 of 277 patients (45.2%) returned surveys: median age was 51 and 22% were African American. The most common PV reported by patients were BRCA2 (25.7%), BRCA1 (19.5%), CHEK2 (20.4%), ATM (8.8%) and PALB2 (7.1%). Disclosure of genetic test results to relatives was quite high: 83.6% of patients reported that they discussed results with all their daughters vs 69.4% with sons; 78.1% discussed their results with all sisters vs 61.8% with all brothers. The median number of patient-reported untested relatives in a family was 9 (25th-75th percentile: 4-14). Most respondents were eligible for the trial offer (113 of 125, 90.4%). Overall, results were similar between the free test arm and $50 test arm: In the free testing arm, 20 patient participants invited 28 relatives; 12 relatives enrolled, and all 12 relatives ordered testing. In the $50 arm, 16 patient participants invited 38 relatives of whom 18 enrolled and all 18 ordered testing. For the 66 relatives invited by the patient participants: 47 (71.2%) were first degree (8 parents, 22 siblings, and 17 children) and about half of the relatives were men (47.0%). Conclusions: Breast cancer patients with PVs make substantial efforts to communicate with family members about genetic risk but most relatives do not receive GT. Our study findings suggest that a low-cost online navigator-supported intervention can directly engage relatives to increase cascade genetic risk education and testing with little difference in uptake by test cost arms.
Why aren’t more patients with breast cancer enrolled in clinical trials?
Authors: Fallon Lalor, Nicole E. Caston, Stacey A. Ingram, Clara Wan, Jesse Sussell, Shilpen A. Patel
Journal: Journal of Clinical Oncology (2022)

84 Background: Only 2-8% of adult patients with cancer participate in clinical trials, likely due to strict exclusion criteria as well as financial and access issues. The primary objective of this study is to understand the population of patients with breast cancer who are and are not offered a clinical trial and the impact of exclusion criteria on enrollment. Methods: Inclusion and exclusion criteria from study protocols housed in OnCore and ClinicalTrials.gov were obtained for breast cancer-specific, therapeutic clinical trials open at the University of Alabama at Birmingham (UAB) from 2016 to 2020. Patients with breast cancer receiving oncology services at UAB from 2016 to 2020 were identified from electronic health records. Race and ethnicity and address were abstracted. Address was utilized to characterize patients as living in areas of higher vs. lower deprivation (Area Deprivation Index) and rural communities (Rural-Urban Commuting Area). Chart abstraction was conducted to assess if patients were offered a trial, eligible for a trial, reason for ineligibility, and enrollment in trial vs standard of care treatment. Results: 518 patients were included; 387 were offered a trial and 131 were not. The median age of patients offered a trial was 57 years old, whereas the median age of patients who were not offered a trial was 61. The majority of patients offered a trial were more often White (72% vs. 24% African American), resided in areas of lower disadvantage (70% vs 17% most disadvantaged), and urban residents (75% vs 13% rural). Of the 387 patients offered a trial, 319 (82%) enrolled, 34 (9%) declined enrollment and chose standard of care, and the remaining 34 (9%) were interested in enrollment but later found to be ineligible. Reasons for ineligibility of the 34 patients who were offered a trial included comorbidities (n = 9), tumor size (n = 7), metastases (n = 5), and previous cancer history (n = 4). Additionally, 9 patients were ineligible for miscellaneous reasons (abnormal labs, age, prescription, trial closed to accrual, tumor characteristics). Of the 131 patients that were not offered a clinical trial, 77 (59%) were ineligible for enrollment. Reasons for ineligibility included: stage 1 disease (n = 35), tumor size and characteristics (n = 24), and comorbidities and abnormal labs (n = 18). The remaining 54 patients would have been eligible, but their provider did not offer a clinical trial. Conclusions: Most patients who are offered a clinical trial are willing to participate; physicians not offering a trial to patients appears to be a driver for low enrollment. Strict exclusion criteria related to comorbidities limit trial participation. Further work is needed to understand the relative importance of these eligibility criteria in relation to validity. Efforts should be made to include patients in clinical trials that reflect the diverse patient population that will receive the drug in the future.
Adverse events associated with androgen receptor signaling inhibitors in the treatment of prostate cancer: A systematic review and network meta-analysis.
Authors: Brent Cao, Melissa Kim, Natalie Marie Reizine, Daniel Moreira
Journal: Journal of Clinical Oncology (2022)

317 Background: Androgen receptor signaling inhibitors (ARSi) are emerging as standard treatments for prostate cancer across the disease spectrum. With multiple available agents approved, comparing adverse effects between different therapies may guide clinical decision-making. The purpose of this meta-analysis was to compare adverse events (AE) and serious adverse events (sAE) between the ARSi drugs abiraterone, apalutamide, darolutamide, and enzalutamide. Methods: PubMed, Web of Science, Embase, and Clinicaltrials.gov were searched for double-blind, randomized controlled trials for ARSi therapy in the treatment of prostate cancer (both metastatic and non-metastatic settings). Two independent teams extracted AE and sAE data. Studies were synthesized using R with the “Netmeta” package. Results: Thirteen double-blinded, randomized trials of abiraterone, apalutamide, darolutamide or enzalutamide were included in this study. The relative risk ratio (RR) of the most common any-grade AE compared to placebo was highest in enzalutamide with a RR of 1.30 (95% confidence interval [CI], 1.13-1.50), followed by apalutamide (1.20, [0.95-1.53]), abiraterone (1.19, [0.98-1.44]), and darolutamide (1.17, [0.83-1.65]). The risk of any sAE was highest in darolutamide (1.80, [0.91-3.57]), followed by apalutamide (1.75, [1.07-2.87]), abiraterone (1.56, [1.08-2.25]), and enzalutamide (1.57, [1.18-2.09]). For overall ARSi analysis, special sAE of interest included acute coronary syndrome, arrhythmia, and seizure, for which ARSi therapy was associated with an odds ratio (OR) of 2.85 (1.65-4.91), 1.75 (1.25-2.44), and 1.31 (0.57-3.00) respectively. Amongst themselves, enzalutamide had the highest risk of cardiovascular AE compared to non-enzalutamide ARSi (RR = 1.77, [1.42-2.20], p &lt; 0.05). Abiraterone had the lowest risk of musculoskeletal AEs compared to non-abiraterone ARSi (0.79, [0.70-0.88], p &lt; 0.05). No significant differences existed in the other domains of interest. Conclusions: ARSi therapy was associated with a higher risk of AE and sAE in various domains compared to placebo. Our findings suggest that the side-effect profiles of ARSis do not significantly differ except in the case of increased cardiovascular risk with enzalutamide and decreased musculoskeletal risk with abiraterone. This data may aid clinicians in determining personalized therapeutic options for their patents based on side effect profiles.